In 1981, Nicholas Gonzalez, a former journalist then in his second year of medical studies, became intrigued by the work of William Donald Kelley, DDS, a Texas orthodontist who had devised a highly unorthodox, nutrition-based method of treating cancer. Kelley claimed to have cured himself of advanced pancreatic cancer using this method alone. He subsequently began treating other cancer patients. Actor Steve McQueen, whose death from mesothelioma in 1980 was widely publicized, was one of Kelley’s patients.
Hoping to achieve mainstream acceptance, Kelley invited Gonzalez to visit his office in Dallas, Texas and granted him unfettered access to his patient records. The book says Gonzalez spent a considerable amount of time combing through them, compiled a monograph that discussed 50 cases, and tried hard to get it published but was unsuccessful. In 2010—23 years after his original compilation—he self-published One Man Alone: An Investigation of Nutrition, Cancer, and William Donald Kelley, a 520-page book that included his original findings plus a preface that describes how his investigation began and the subsequent unraveling of his relationship with Kelley. Each case history consists
of a narrative by Gonzalez and copies of some supporting medical records.
Gonzalez stated that his investigation was supervised over a long period by the prominent cancer specialist and educator Robert A. Good, M.D., Ph.D. However, letters from Dr. Good indicate that although he provided advice, he was extremely skeptical of Kelley’s work and repeatedly asked Gonzalez to stop using his name and reputation to “promulgate a treatment that may be pure quackery.” [1]
How Cancer Treatments Can Be Judged
The Kelley treatment is just one of countless nonstandard cancer treatments promoted in recent decades. Such treatments have two common attributes. First, they are based upon poorly supported or largely discredited theories of cancer. Second, they are promoted with anecdotes and testimonials rather than appropriately designed studies. (All such methods, no matter how improbable, seem able to accumulate some.)
Promoters of nonstandard cancer treatments often claim that mainstream medicine’s rejections are governed by unjustified biases or ignoble motives. However, if a treatment actually works, it should be fairly easy to demonstrate effectiveness by accumulating appropriate data. To be compelling, cases intended to demonstrate a cure would require:
- A firm diagnosis of invasive cancer of a type that has predictable behavior. This usually requires biopsy evidence, but some diagnoses can be reliably based on imaging and/or laboratory tests.
- That all signs of cancer abate with the use of the treatment being assessed, with that treatment alone, and within a time frame consistent with a causal relationship
- That the patient stays cancer-free long enough to conclude that a cure has occurred or the tumor is unlikely to recur. For example, because colorectal cancer usually recurs within 5 years of treatment if it has not been eradicated, colorectal cancer patients who remain cancer-free for 5 years are likely to have been cured. But some cancers require much longer follow-up time to judge.
Even a few well-documented and confirmable cases with these specific qualities within the recent experience of a single practitioner or clinic would suggest that a cancer treatment is worth pursuing. If the type of cancer is known to regularly undergo spontaneous remission—as are certain lymphomas, renal cell cancer, melanoma, chronic lymphocytic leukemia, and childhood neuroblastoma—more cases would be needed, but the required evidence would be similar.
Our Findings
None of the 50 cases Gonzalez reports satisfy the above criteria. At least 41 of the patients had been treated with surgery, radiation, and/or chemotherapy that could have been responsible for the length of their survival. The rest lacked biopsy evidence and/or had cancers that typically have long survival times. The table below summarizes our findings. We have also posted a detailed analysis of each case [2].
| Patient # | Kelley’s Presumed Diagnosis |
Biopsy? |
Conventional Therapy? |
| 1 | Bile duct carcinoma |
No |
Radiation |
| 2 | Brain cancer |
Probable lymphoma |
Radiation |
| 3 | Metastatic breast cancer |
Not of distant metastases |
Surgery, chemotherapy |
| 4 | Locally recurrent breast cancer |
Yes |
Surgery |
| 5 | Metastatic breast cancer |
Yes |
Surgery |
| 6 | Metastatic breast cancer |
Not of suspected distant metastases |
Chemotherapy |
| 7 | Breast cancer |
Not of suspected distant metastases |
Surgery |
| 8 | Carcinoma of cervix |
Not of suspected recurrence |
Radiation |
| 9 | Colon cancer |
Not of suspected disease progression |
Surgery |
| 10 | Metastatic colon cancer |
Not of two suspected liver lesions |
Surgery |
| 11 | Colon cancer |
Not of suspected recurrence |
Surgery |
| 12 | Hodgkin lymphoma |
Not of recurrence described |
Not of presumed relapse |
| 13 | Hodgkin lymphoma |
Yes |
Chemotherapy |
| 14 | Hodgkin lymphoma |
Yes |
Chemotherapy |
| 15 | Hodgkin lymphoma |
Yes |
Chemotherapy |
| 16 | Acute lymphatic leukemia |
Yes |
Chemotherapy |
| 17 | Acute myleocytic leukemia |
Yes |
Chemotherapy |
| 18 | Chronic myelogenous leukemia |
Yes |
Chemotherapy |
| 19 | Liver metastases from unknown primary |
Yes |
Chemotherapy |
| 20 | Metastatic lung cancer |
Not of presumed metastases |
Surgery |
| 21 | Lung cancer |
Yes |
Radiation |
| 22 | Non-Hodgkin’s lymphoma |
Yes |
Chemotherapy |
| 23 | Non-Hodgkin’s lymphoma |
Yes |
Radiotherapy |
| 24 | Non-Hodgkin’s lymphoma |
Yes |
Radiation |
| 25 | Non-Hodgkin’s lymphoma (lymphoma cutis) |
Yes |
Surgery |
| 26 | Non-Hodgkin’s lymphoma |
Yes |
Radiation |
| 27 | Non-Hodgkin’s lymphoma |
Yes |
Nil |
| 28 | Malignant melanoma |
Not of supposed recurrence |
Nil |
| 29 | Malignant melanoma |
Yes |
Surgery |
| 30 | Malignant melanoma |
Yes |
Surgery |
| 31 | Multiple myeloma |
Yes |
Chemotherapy |
| 32 | Ovarian cancer |
Yes |
Surgery, radiation, chemotherapy |
| 33 | Ovarian cancer |
Yes |
Surgery, radiation |
| 34 | Metastatic pancreatic cancer |
Yes of small liver nodule but not |
Nil |
| 35 | Metastatic islet cell carcinoma of pancreas |
Yes of liver, but not of pancreas |
Chemotherapy |
| 36 | Pancreatic cancer |
Yes |
Surgery |
| 37 | Carcinoid |
Yes |
Surgery |
| 38 | Pancreatic cancer with liver metastases |
No |
No |
| 39 | Prostate cancer |
Yes |
Surgery |
| 40 | Prostate cancer |
Yes |
Surgery, chemotherapy |
| 41 | Prostate cancer |
Yes |
Surgery, chemotherapy |
| 42 | Prostate cancer |
Yes |
Nil? |
| 43 | Prostate cancer |
Yes |
Surgery, radiation, chemotherapy |
| 44 | Rectal cancer |
Yes |
Surgery |
| 45 | Colorectal cancer |
Yes |
Surgery, chemotherapy |
| 46 | Renal cancer |
Yes |
Surgery, radiation, chemotherapy |
| 47 | Gastric cancer |
Yes |
Surgery |
| 48 | Testicular cancer |
Yes |
Surgery |
| 49 | Testicular cancer |
Yes |
Surgery |
| 50 | Carcinoma body of uterus |
Yes |
Surgery, radiation, chemotherapy |
In 1987, Gonzalez opened an office in New York where he began administering treatment adapted from Kelley’s ideas. In 1998, researchers at Columbia University organized a study that was subsequently funded by the National Cancer Institute and the National Center for Complementary and Alternative Medicine. However, it was difficult to recruit patients, the protocol was changed several times, and the project took close to ten years to complete.
The completed study, which compared Gonzalez therapy with standard chemotherapy for inoperable pancreatic cancer, was released online in 2009 in the Journal of Clinical Oncology. The researchers followed 55 patients, 23 of whom chose chemotherapy and 32 who chose Gonzalez’s treatment, which included pancreatic enzymes, nutritional supplements, “detoxification” with coffee enemas, and an “organic food” diet. At enrollment, the treatment groups had no statistically significant differences in patient characteristics, pathology, quality of life, or clinically meaningful laboratory values. When the study ended, the chemotherapy patients had a median survival of 14 months, whereas the enzyme-treated groups had a median survival of 4.3 months (the expected result for people who have no treatment). At 1 year, 56% of chemotherapy-group patients were alive, but only 16% of enzyme-therapy patients were alive. The quality-of-life ratings were also worse in the enzyme-treated group than in the chemotherapy group [3].
In July 2015, Gonzalez’s office announced that he had suddenly collapsed and died, apparently of a heart-related cause.
References
- Barrett S. Dr. Robert A. Good’s opinion of
Gonzalez’s metabolic therapy. Cancer Treatment Watch, March 29, 2015. - Moran PJ, Lubetkin L. One Man Alone: Fifty Cases Treated by the Kelley Method as presented by Nicholas Gonzalez, M.D., Dec 21, 2014.
- Chabot JA and others. Pancreatic proteolytic enzyme therapy compared with gemcitabine-based chemotherapy for the treatment of pancreatic cancer. Journal of Clinical Oncology 28:2058-2063, 2010.
This article was revised on July 24, 2015.
